Medtronic MIRRO MRI implantable defibrillator recalled for weld defect
Medtronic is recalling 3 MIRRO MRI DR SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality checks. The defect was detected during manufacturing before devices reached patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with a weld crack defect in a critical cardiovascular application. Although the manufacturing defect poses significant potential risk to implanted devices, no illnesses or injuries have been reported, and the manufacturing process detected the flaw before any devices reached patients.
Plain-English summary
Medtronic Inc. is recalling 3 units of the MIRRO MRI DR SureScan (Model DDME3D1) implantable cardioverter defibrillator due to a manufacturing defect. A weld crack caused the devices to fail quality checks during manufacturing's leak testing step.
The affected units (serial numbers CWS604689S, CWS604691S, and CWS604694S) were distributed worldwide to patients and healthcare facilities. The defect was identified during manufacturing quality testing before any devices were implanted in patients. Patients or healthcare providers who may have affected devices should contact Medtronic or their physician for further guidance.
The recalled product
- Product
- MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- GTIN: 00763000001568
- Serial Numbers: CWS604689S
- CWS604691S
- CWS604694S
Distribution
Part of a larger recall action
This product is one of 23 recalled by Medtronic Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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